FDA-Device2026-02-11Class IIMISBRANDING
Vivoo Vaginal pH Test recalled for inaccurate results and unapproved marketing
FALSE CLAIMSNationwide distribution
Stop using Vivoo Vaginal pH Test strips
Vivoo Vaginal pH Test strips were sold in the U.S. before receiving required FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical treatment based on incorrect information.
- Stop using the Vivoo Vaginal pH Test
- Do not rely on results from strips you may have already used
- Consult your doctor if you have health concerns about vaginal pH or symptoms
- Contact the manufacturer or retailer about how to return or discard the product
Hazard
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
3,000
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Vivoo Vaginal pH Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1266-2026Don't want to check this manually?
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